<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
48433-324-10
</NDCCode>
<PackageDescription>
100 POUCH in 1 BOX, UNIT-DOSE (48433-324-10) > 1 TABLET, FILM COATED in 1 POUCH (48433-324-01)
</PackageDescription>
<NDC11Code>
48433-0324-10
</NDC11Code>
<ProductNDC>
48433-324
</ProductNDC>
<ProductTypeName>
HUMAN PRESCRIPTION DRUG
</ProductTypeName>
<ProprietaryName>
Quetiapine Fumarate
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Quetiapine Fumarate
</NonProprietaryName>
<DosageFormName>
TABLET, FILM COATED
</DosageFormName>
<RouteName>
ORAL
</RouteName>
<StartMarketingDate>
20140930
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
ANDA
</MarketingCategoryName>
<ApplicationNumber>
ANDA091388
</ApplicationNumber>
<LabelerName>
Safecor Health, LLC
</LabelerName>
<SubstanceName>
QUETIAPINE FUMARATE
</SubstanceName>
<StrengthNumber>
25
</StrengthNumber>
<StrengthUnit>
mg/1
</StrengthUnit>
<Pharm_Classes>
Atypical Antipsychotic [EPC]
</Pharm_Classes>
<DEASchedule/>
<Status>
Deprecated
</Status>
<LastUpdate>
2019-11-27
</LastUpdate>
<PackageNdcExcludeFlag/>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20191231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage/>
<EndMarketingDatePackage/>
<SamplePackage/>
</NDC>